Materialise NV (Leuven, Belgium), a supplier of additive manufacturing software and 3D printing services to the medical and industrial sectors, has listed its 3D-printed cardiovascular HeartPrint models as a medical device in the U.S. and EU markets. The company has used 3D printing to fabricate anatomical models for educational and research purposes for many years; this move strengthens its unique position in the market, says Materialise in a press release, and is a natural extension of the Mimics Innovation Suite of software for medical image processing, which has 510(k) clearance and a CE mark.
By listing HeartPrint as a Class I medical device, Materialise is able to add HeartPrint models to its portfolio of pre-operative planning tools. The 3D-printed, patient-specific cardiovascular models are created from medical image data to provide cardiologists and surgeons with supplemental information to determine the best treatment for each patient.
"Where I think 3D printing will take us clinically is to the next generation of imaging. As we've seen in the history of medicine, the better our imaging, the more precise we are pre-operatively to be able to say what operation we're going to do," said David Morales, MD, Chief of Cardiovascular Surgery for the Heart Institute at Cincinnati Children's Hospital Medical Center.